Background:

Typical patients with gout have multiple comorbidities such as metabolic and cardiovascular (CV) disorders, hypertension, and kidney disease; concern for these conditions can make gout treatment conditions complex. This post hoc analysis was conducted to examine the relationship of age and comorbidities (renal, hepatic, CV function, and body mass index [BMI]) on the adverse event (AE) profile of patients with acute gout who were treated with colchicine.

Results:

At baseline, patients had a mean age of 51.5 (standard deviation [SD]= 11.1) years, with a diagnosed gout duration of 10.5 (SD = 8.9) years, a BMI of 33.0 (SD = 5.7), and serum uric acid level of 8.8 (SD = 1.8) mg/dL, and had experienced >=2 acute gout flares in the 12 months before enrollment. Across the study, 83 patients (~45%) experienced an AE; most of these were mild to moderate gastrointestinal AEs (~73%). Incidence of AEs in patients treated with colchicine was not significantly affected by any of the independent variables analyzed in this study (Table). Additional sensitivity analyses using cutoffs of 3 × ULN for AST (n = 0), ALT (n = 0), and alkaline phosphatase (n = 1), and 3.0 g/L for albumin (n = 0), were not performed because numbers of patients meeting these criteria were negligible.

Table

Independent baseline variables analyzed

Patients, n (%)

Odds ratio

95% Confidence interval

P value

Age (continuous)

185 (100.0)

1.00

0.97, 1.03

0.999

BMI >30

125 (67.6)

1.22

0.63, 2.37

0.548

Gout duration >8 years

91 (49.2)

1.24

0.68, 2.25

0.476

Cardiovascular history (yes/no)

107 (57.8)

1.13

0.60, 2.10

0.707

Creatinine clearance >=60 mL/min

161 (87.0)

0.87

0.34, 2.22

0.778

AST > ULN

12 (6.5)

1.19

0.31, 4.61

0.805

ALT > ULN

31 (16.8)

0.57

0.23, 1.44

0.236

Albumin <=3.5 g/L

0







Alkaline phosphatase > ULN

2 (1.1)

1.04

0.06, 19.01

0.976

Conclusions:

In these regression analyses of 185 patients with gout in a randomized phase 3 study, there was no effect of chronologic age, gout duration, renal function (indicated by creatinine clearance), liver function (as assessed by AST, ALT, albumin, and alkaline phosphatase), presence of CV history, or obesity with the incidence of AEs following colchicine treatment (inclusive of all doses). Although additional studies would be needed to corroborate these results, these data offer reassurance regarding the safety of colchicine in patients with several comorbid conditions.